An interventional study of Surgery with Preceyes Robot plus NHS standard of care in Retinal Vein Occlusion (RVO), sponsored by University of Oxford. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Oxford · Not applicable, Interventional, and Other
Retinal vein occlusions (RVOs) are the second leading cause of permanent vision loss in the UK. Current treatments, like anti-VEGF injections or steroids, address complications such as macular fluid but do not target the underlying issue-a clot in the retinal vein. Direct injection of clot-dissolving agents, such as tissue plasminogen activator (tPA), is challenging due to the small size of retinal veins. This surgical trial aims to inject tPA directly into the blocked retinal vein to dissolve the clot and restore blood flow.
This surgical trial aims to inject tPA directly into the blocked retinal vein to dissolve the clot and restore blood flow. Robotic assistance will stabilise the injection cannula, ensuring precise and slow infusion of tPA. This study will compare outcomes in patients receiving standard care for RVOs (the control group) with those receiving standard treatment plus the robot-assisted tPA injection (the study group). The robotic system has been clinically validated and has received CE marking for vitreoretinal interventions, including tPA injection beneath the retina.
tPA has been safely used in the eye with no reported safety concerns. It is licensed for intravenous use for thromboembolic events that lead to ischemia. RVO (an ischemic stroke of the eye) is a specific example. Instead of systemic administration through the peripheral vein, we will be directly delivering tPA into the occluded retinal vein, effectively treating the localised ischemia, within licensed intent.
40 eligible participants diagnosed with RVO will be recruited from the NHS clinic. Participants will be randomly allocated to the control group or the study group and will be monitored for 12 months. The study focuses on safety as the primary outcome and efficacy in terms of retinal structure and function as secondary outcomes. If successful, this trial could lead to a new intervention for RVO-related vision loss.
289 studies on the registry are indexed under Retinal Vein Occlusion; 32 are open to participants now.
This study's planned enrollment of 40 is below the median of 51 across 208 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomised to the control arm will receive NHS standard of care surgery.
Participants randomised to the interventional arm will receive robot-assisted vein cannulation and infusion into the blocked vein during the NHS standard of care surgery.
Procedure: Surgery with Preceyes Robot plus NHS standard of care
Central Retinal Vein cannulation and infusion into the blocked vein using the Preceyes Robot, while following NHS standard of care
Safety of robot-assisted retinal vein cannulation
Evaluation of safety will be based on the potential number of procedure-related adverse events.
Time frame: Baseline to 12 months
To evaluate change in visual acuity
Mean change from baseline to Month 12 in Best-Corrected Visual Acuity (BCVA) as measured by the Early Treatment of Diabetic Retinopathy (ETDRS) Chart
Time frame: Baseline to 12 months
To evaluate change in central macular thickness
Mean change in central macular thickness from baseline to Month 12 as measured with spectral domain optical coherence tomography ( SD-OCT)
Time frame: Baseline to 12 months
To evaluate changes in area of the non-perfused retina
Change in area of the non-perfused retina from baseline to Month 12 as measured with fundus fluorescein angiography (FFA).
Time frame: At all protocol-specified visits with the endpoint at 12 months.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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